Clinical Trials

In advanced biological and biomedical research, which is the core focus of BIONET’s work on issues of ethical governance, clinical trials increasingly act as an ‘obligatory point of passage’ in translation work from bench to bedside. While clinical trials have primarily been used to test new drugs since the 1950s and 60s when legislation in America and Europe made it mandatory for drug companies to provide evidence of safety and efficacy, one biotech CEO has predicted that in the 21st century “living cells will be tomorrow’s pharmaceuticals”. And so, as more efforts are made to translate advanced biological research into stem cell and gene therapies, they will become increasingly subject to clinical trials. At the same time, the offshoring of clinical trials via clinical research organisations has become a common practice among multinational pharmaceutical companies. A number of concerns have been raised about the ‘ethical variability’ that this has engendered with differing guidelines and regulations found in different countries. There are also concerns about the relevance of clinical research to the populations from where research subjects are recruited as well as about benefit sharing and ethical oversight. Finally, with increasing research into pharmacogenomics, clinical trials are being used, not just to test the safety and efficacy of certain drugs, but also to identify genetic markers which might predict those who respond well to a drug from those who do not.